SPECIAL CONCERNS
Aripiprazole ■E
(a h- r ih -PI P- ra h- z o hl)
CLASSIFICATION(S):
Antipsychotic
PREGNANCY CATEGORY: C
Rx: Abilify, Abilify Discmelt.
USES
PO. (1) Acute and maintenance treat-
ment of schizophrenia in adults and ad-
olescents 13-17 years of age. (2) Mono-
therapy in adults and children 10-17
years of age for acute and maintenance
treatment of manic and mixed episodes
with bipolar I disorder with or without
psychotic features. (3) Adjunctive ther-
apy to either lithium or valproate in
adults and children 10-17 years of age
for acute treatment of manic and mixed
episodes associated with bipolar I disor-
der with or without psychotic features.
(4) Adjunctive treatment to antidepres-
sants for major depressive disorder. In-
vestigational: Restless legs syndrome.
IM only. Acute treatment of agita-
tion associated with schizophrenia or
biopolar disorder (manic or mixed) in
adults.
ACTION/KINETICS
Action
Mechanism not known with certainty
but likely due to high affinity for dop-
amine D2 (partial agonist) and D3 recep-
tors as well as 5-HT1A (partial agonist)
and antagonist activity at 5-HT2A recep-
tors. Low incidence of sedation and or-
thostatic hypotension.
Pharmacokinetics
Well absorbed (87% bioavailable). Peak
plasma levels: 3–5 hr. A high fat meal
1
will delay the Tmax. t /2, elimination: 75
hr for extensive metabolizers and 146
hr for poor metabolizers. Metabolized
by CYP2D6 and CYP3A4 enzymes in the
liver. Excreted through both the feces
(about 55%) and urine (about 25%).
Plasma protein binding: >99% bound
to plasma proteins.
CONTRAINDICATIONS
Lactation. Use in those with dementia-
related psychosis. Use of alcohol.
C = see color insert H = Herbal
■ (1) Elderly clients with dementia-re- A
lated psychosis treated with atypical an-
tipsychotic drugs are at an increased
risk of death, compared with placebo.
Analyses of placebo-controlled trials
(modal duration, 10 weeks), in these in-
dividuals revealed a risk of death in the
drug-treated clients of between 1.6 to
1.7 times that seen in placebo-treated
clients. Over the course of a typical 10-
week controlled trial, the rate of death
in drug-treated clients was about 4.5%
compared with a rate of about 2.6% in
the placebo group. Although the causes
of death were varied, most of the
deaths appeared to be either cardiovas-
cular (e.g., heart failure, sudden death)
or infections (e.g., pneumonia) in na-
ture. Aripiprazole is not approved for
the treatment of clients with dementia-
related psychosis. (2) Compared with
placebo, antidepressants increased the
risk of suicidal thinking and behavior
(suicidality) in children, adolescents,
and young adults in short-term studies
of major depressive disorder and other
psychiatric disorders. Anyone consider-
ing the use of adjunctive aripiprazole or
any other antidepressant in a child, ad-
olescent, or young adult must balance
this risk with the clinical need. Short-
term studies did not show an increase
in the risk of suicidality with antidepres-
sants compared with placebo in adults
older than 24 years of age; there was a
reduction in the risk with antidepres-
sants compared with placebo in adults
65 years of age and older. Depression
and certain other psychiatric disorders
are themselves associated with in-
creases in the risk of suicide. Clients of
all ages who are started on antidepres-
sant therapy should be monitored ap-
propriately and observed closely for
clinical worsening, suicidality, or unusu-
al changes in behavior. Families and
caregivers should be advised of the
need for close observation and commu-
nication with the prescriber. Aripipra-
zole is not approved for use in children
with depression.■ Long-term efficacy
has not been established. Use with cau-
tion in history of MI, ischemic heart dis-
IV = Intravenous
E = sound alike drug
 2 ARIPIPRAZOLE
ease, heart failure, conduction abnor-
A malities, cerebrovascular disease, or
conditions that predispose to hypoten-
sion (e.g., dehydration, hypovolemia,
antihypertensive drug treatment).
There is an increased risk of hyperglyce-
mia and diabetes. Use with caution in
conditions that may contribute to an
increase in body temperature and in
those at risk for aspiration pneumonia.
Safety and efficacy in psychosis associ-
ated with dementia, in psychosis associ-
ated with Alzheimer’s disease, or in chil-
dren and adolescents have not been
evaluated.
SIDE EFFECTS
Most Common
Headache, agitation, insomnia, dyspep-
sia, constipation, N&V, drowsiness/seda-
tion/somnolence.
Neuroleptic Malignant Syndrome: Hyper-
pyrexia, muscle rigidity, altered mental
status, autonomic instability, rhabdo-
myolysis, acute renal failure. CNS: Tar-
dive dyskinesia, seizures, somnolence,
headache, anxiety, insomnia, lighthead-
edness, akathisia, dyskinesia, tremor,
depression, nervousness, hostility, man-
ic reaction, abnormal gait, confusion,
cogwheel rigidity, dystonia, twitch, im-
potence, bradykinesia, decreased or in-
creased libido, panic attack, impaired
memory, stupor, amnesia, hyperactivity,
depersonalization, hypokinesia, restless
leg syndrome, dysphoria, neuropathy,
increased reflexes, slowed thinking, hy-
perkinesia, hyperesthesia, hypotonia,
oculogyric crisis, suicidal thought, sui-
cide. GI: N&V, constipation, increased
salivation, anorexia, gastroenteritis, dys-
phagia, flatulence, gastritis, tooth caries,
gingivitis, hemorrhoids, gastroesopha-
geal reflux, GI hemorrhage, periodontal
abscess, tongue edema, fecal inconti-
nence, colitis, rectal hemorrhage, sto-
matitis, mouth ulcer, cholecystitis, fecal
impaction, oral moniliasis, cholelithiasis,
eructation, intestinal obstruction, peptic
ulcer. CV: Hypertension, tachycardia,
hypotension, bradycardia, palpitation,
hemorrhage, MI, CVA, cardiac arrest,
heart failure, prolonged QT interval,
atrial fibrillation, AV block, myocardial
ischemia, phlebitis, DVT, angina pecto-
Bold Italic = life threatening side effect
■ = black box warning
ris, extrasystoles. Hematologic: Ecchy-
mosis, anemia, hypochromic anemia,
leukopenia, leukocytosis, lymphade-
nopathy, thrombocytopenia, iron defi-
ciency anemia. Musculoskeletal: Mus-
cle cramps, arthralgia, bone pain, myas-
thenia, arthritis, arthrosis, muscle weak-
ness, spasm, bursitis. Body as a whole:
Asthenia, fever, weight gain or loss, flu
syndrome, peripheral edema, chills,
bloating, diabetes mellitus, edema, de-
hydration, thirst. Metabolic: Hypergly-
cemia, sometimes associated with ke-
toacidosis, hyperosmolar coma, or
death. Respiratory: Rhinitis, coughing,
chest tightness, dyspnea, pneumonia,
asthma, epistaxis, hiccup, laryngitis.
Dermatologic: Dry skin, rash, pruritus,
sweating, skin ulcer, acne, vesiculobul-
lous rash, eczema, alopecia, psoriasis,
seborrhea. GU: Urinary incontinence,
cystitis, leukorrhea, urinary frequency/
urgency/retention, hematuria, dysuria,
amenorrhea, abnormal ejaculation, va-
ginal hemorrhage, vaginal moniliasis,
kidney failure, uterine hemorrhage, me-
norrhagia, kidney calculus, nocturia,
polyuria. Ophthalmic: Blurred vision,
conjunctivitis, dry eye, eye pain, cata-
ract, blepharitis. Otic: Ear pain, tinnitus,
otitis media. Miscellaneous: Accidental
injury, chest/neck/jaw pain, jaw
tightness, enlarged abdomen, neck ri-
gidity, pelvic pain, hypothyroidism, al-
tered taste.
LABORATORY TEST CONSIDERATIONS
앖 CPK, AST, ALT, BUN, alkaline phos-
phatase, creatinine, LDH. Hypercholes-
terolemia, hyper-/hypoglycemia, hypo-
kalemia, hyperlipemia, hyponatremia,
bilirubinemia.
DRUG INTERACTIONS
Carbamazepine / 앖 Aripiprazole clear-
ance 씮 앗 blood levels R/T induction of
CYP3A4 enzymes; double the aripipra-
zole dose
Clarithromycin / 앗 Aripiprazole metab-
olism 씮 앖 blood levels R/T inhibition
of CYP3A4 enzymes; reduce aripipra-
zole to one-half the usual dose
Fluoxetine / 앗 Aripiprazole metabolism
씮 앖 blood levels R/T inhibition of
CYP2D6 enzymes; reduce aripiprazole
dose to at least one-half the usual dose
W = Available in Canada

Ketoconazole / 앗 Aripiprazole metabo-
lism 씮 앖 blood levels R/T inhibition of
CYP3A4 enzymes; reduce aripiprazole
to one-half the usual dose
Paroxetine / 앗 Aripiprazole metabolism
씮 앖 blood levels R/T inhibition of
CYP2D6 enzymes; reduce aripiprazole
to one-half the usual dose
Quinidine / 앗 Aripiprazole metabolism
씮 앖 blood levels R/T inhibition of
CYP2D6 enzymes; reduce aripiprazole
to one-half the usual dose
HOW SUPPLIED
Injection: 7.5 mg/mL; Oral Solution: 1
mg/mL; Tablets: 2 mg, 5 mg, 10 mg, 15
mg, 20 mg, 30 mg; Tablets, Orally Disin-
tegrating (Discmelt): 10 mg, 15 mg.
DOSAGE
• ORAL SOLUTION; TABLETS; TAB-
LETS, ORALLY DISINTEGRATING
Schizophrenia, adults.
Initial and target dose: 10 or 15
mg/day given on a once-a-day sched-
ule. Effective dose range: 10–30
mg/day. Do not make dosage increases
before 2 weeks, the time required to
reach steady state. Maintenance: Has
been used for periods up to 6 months.
Periodically assess to determine the
need for maintenance treatment.
Schizophrenia, adolescents.
Initial: 2 mg. Usually titrated to 5 mg
after 2 days and to the target dose of 10
mg/day after 2 additional days. Give
subsequent dose increases in 5-mg in-
crements. A 30 mg/day dose is not
more effective than a 10 mg/day dose.
Can be given without regard to meals.
Maintenance: Those responding can
be continued beyond the acute re-
sponse; ue the lowest dose needed to
maintain remission. Periodically assess
to determine the need for maintenance
treatment.
Bipolar disorder.
Adults, initial and target dose: 15 mg
as monotherapy or as adjunctive ther-
apy with lithium or valproate given
once a day without regard to meals.
The dose may be increased to 30
mg/day based on clinical response.
Doses above 30 mg/day have not been
evaluated. Maintenance: May be used
for up to 6 weeks; data are not available
C = see color insert H = Herbal
ARIPIPRAZOLE 3
to support treatment beyond 6 weeks.
Children, 10–17 years of age, initial: A
2 mg/day; titrate to 5 mg/day after 2
days and to the target dose of 10
mg/day after 2 additional days when
used as monotherapy or as adjunctive
therapy. Make subsequent dose in-
creases in increments of 5 mg/day.
Maintenance: Responding clients can
be continued beyond the acute re-
sponse but at the lowest dose needed
to maintain remission. Periodically ass-
ess to determine the need for mainte-
nance therapy.
Adjunct to antidepressants for major
depressive disorder.
Adults, initial: 2-5 mg/day. Adjust dos-
age of up to 5 mg/day gradually, at
intervals of no less than 1 week; doses
up to 15 mg/day have been used. Long-
term efficacy has not been determined;
periodically assess to determine the
need for maintenance treatment. Effica-
cy has not been determined for adjunc-
tive treatment of major depressive dis-
order in children.
• INJECTION (IM ONLY)
Agitation associated with schizophre-
nia or bipolar mania.
Adults, initial: 9.75 mg; dose range:
5.25–15 mg. If agitation persists follow-
ing the initial dose, cumulative doses
up to 30 mg/day may be given. The
safety of total daily doses greater than
30 mg or injections given more fre-
quently than q 2 hr have not been ade-
quately evaluated. If ongoing therapy is
indicated, PO aripiprazole in a dose
range from 10–30 mg/day should re-
place the injection as soon as possible.
The injection has not been evaluated in
children.
NURSING CONSIDERATIONS
E Do not confuse aripiprazole with lan-
soprazole (proton pump inhibitor).
ADMINISTRATION/STORAGE
1. If switching from other antipsychot-
ics, minimize period of overlapping an-
tipsychotic administration.
2. Oral solution can be given on a mg-
per-mg basis in place of the 5, 10, 15, or
20 mg tablets strengths. Clients receiv-
IV = Intravenous
E = sound alike drug
 4 ARIPIPRAZOLE
ing 30 mg tablets should receive 25 mg
A of the solution.
3. The dosing for the orally disintegrat-
ing tablets is the same as for the oral
tablets.
4. To administer the injection, draw up
the required volume of solution as fol-
lows: 0.7 mL for the 5.25 mg dose, 1.3
mL for the 9.75 mg dose, and 2 mL for
the 15 mg dose. Inject slowly deep in
the muscle mass. Discard any unused
portion.
5. Do not give the injection IV or SC.
6. Opened bottles of solution can be
used for up to 6 months after opening
if refrigerated.
7. Reduce the dose of aripiprazole to
one-half the usual dose if given with
CYP3A4 inhibitors (e.g., clarithromycin,
ketoconazole). When the CYP3A4 inhib-
itor is withdrawn, increase the dose of
aripiprazole.
8. Reduce the dose of aripiprazole to at
least one-half the usual dose if given
with potential CYP2D6 inhibitors (e.g.,
fluoxetine, paroxetine, quinidine). When
the CYP2D6 inhibitor is withdrawn, in-
crease the dose of aripiprazole.
9. Double the dose of aripiprazole if
given with a potential CYP3A4 inducers
(e.g., carbamazepine). Base additional
increases in dose based on clinical eval-
uation. When the CYP3A4 inducer is
withdrawn, reduce the dose of aripipra-
zole to 10 or 15 mg.
10. Protect the injection from light by
storing in the original container. Keep
in carton until time of use.
11. Store the injection, tablets, and oral
solution between 15–30°C (59–86°F).
ASSESSMENT
1. Identify behaviors/conditions requir-
ing management, other agents trialed
and outcome.
2. List drugs prescribed; ensure no in-
teractions or dosage adjustments need-
ed.
3. Assess mental status, evidence/histo-
ry of CAD, hypo-/hypertension. Use cau-
tiously with CAD, seizure history, or
conditions that lower seizure threshold
e.g., Alzheimer’s dementia. Use caution,
has caused fatal heart attack and stroke
Bold Italic = life threatening side effect
■ = black box warning
in older adults with dementia-related
conditions.
4. Monitor VS, ECG, I&O, lipid panel, BS,
electrolytes, CPK, renal, LFTs and for evi-
dence of diabetes.
5. Aripiprazole has been given for up to
26 weeks, although it can be used for
longer-term efficacy; assess clients peri-
odically to determine need for mainte-
nance therapy.
• DSM III/IV-TR criteria for schizophre-
nia: delusions, conceptual disorgani-
zation, hallucinatory behavior, ex-
citement, grandiosity, suspi-
ciousness/persecution, and hostility.
• PANSS (Positive and Negative Syn-
drome Scale) should include 7+
symptoms of schizophrenia: blunted
affect, emotional withdrawal, poor
rapport, passive apathetic withdraw-
al, difficulty with abstract thinking,
lack of spontaneity/flow of conversa-
tion, stereotypical thinking).
CLIENT/FAMILY TEACHING
1. Take with or without food once daily
with a full glass of water.
2. Do not split the orally disintegrating
tablets.
3. With diabetes, each mL of Abilify oral
solution contains 400 mg of sucrose
and 200 mg of fructose.
4. Avoid activities that require mental
alertness until drug effects realized;
may impair judgment, thinking, or mo-
tor skills.
5. Change positions slowly; prevents
sudden drop in BP.
6. Practice reliable contraception, re-
port if pregnancy suspected.
7. Avoid alcohol, CNS depressants, OTC
agents, strenuous exercise, exposure to
extreme heat, overheating, or dehydra-
tion.
8. May cause esophogeal dysmotility-
may cause aspiration; use caution.
9. Do not add any medications or OTC
agents without provider approval due
to the potential for strong drug interac-
tions.
10. Immediately report any S&S of NMS
(neuroleptic malignant syndrome): in-
creased temperature, muscle rigidity, ir-
regular heart rate/BP, arrhythmias or se-
W = Available in Canada
 ARIPIPRAZOLE 5
vere diaphoresis. Avoid becoming over- of treatment needed. Psychiatric ther-
heated or dehydrated. apy and evaluation should be regular A
11. Report any movements that be- and ongoing.
come involuntary, slow, repetitive, OUTCOMES/EVALUATE
rhythmical (tardive dyskinesia) in select • Improvement in PANSS and DSM III/
or groups of muscles; may become irre- IV-TR schizophrenia criteria
versible. • Evidence of improved behavioral and
12. Prescriptions will be for small emotional presentation
amounts to prevent overdose and for • 앗 Delusions/suspiciousness and
the smallest dose and shortest duration hostility

C = see color insert H = Herbal IV = Intravenous

E = sound alike drug